Laser and LED Therapy on Elderly Individuals With Temporomandibular DisorderPhase 2NCT03257748
Effects of Laser Therapy and LED Therapy on Elderly Individuals With Temporomandibular Disorder
A Phase 2 study testing Laser Therapy and LED therapy in people with Laser and LED Therapy on Elderly Individuals With Temporomandibular Disorder, run by University of Nove de Julho at 1 site in Brazil.
Trial summary
Temporomandibular disorder (TMD) is described as a subgroup of orofacial pain with a set of signs and symptoms that involve the temporomandibular joint, masticatory muscles, ears and neck. TMD can occur unilaterally or bilaterally and approximately 70% of the population is affected with at least one sign. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Laser and LED Therapy on Elderly Individuals With Temporomandibular Disorder
- What is being tested?
- Laser Therapy and LED therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteBrazil
- Study dates
- 1 May 2017to 20 Dec 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of TMD based on the RDC/TMD;
- Age between 40 and 70 years.
Who cannot join
- Dentofacial anomalies;
- Currently in orthodontic or orthopedic treatment for the jaw;
- Currently undergoing physical therapy;
- Currently undergoing psychological treatment;
- Use of muscle relaxant or anti-inflammatory agent.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
UniNove
São Paulo, São Paulo, 01504001
Sandra K Bussadori, Ms, +55 11 26339000, sandra.skb@gmail.com
About this study
Official title: Effects of Laser Therapy and LED Therapy on Elderly Individuals With Temporomandibular Disorder: a Randomized, Controlled, Double-blind, Clinical Trial
Temporomandibular disorder (TMD) is described as a subgroup of orofacial pain with a set of signs and symptoms that involve the temporomandibular joint, masticatory muscles, ears and neck. TMD can occur unilaterally or bilaterally and approximately 70% of the population is affected with at least one sign. The disorder progresses with orofacial pain, muscle pain involving the masticatory and cervical muscles, joint noises (clicks and pops), joint block, mandibular dysfunction and headache. The etiology can be abnormal occlusion and/or posture, trauma involving local tissues, repetitive microtrauma, parafunctional habits and an increase in emotional stress. Studies have demonstrated that phototherapy is an efficient option for the treatment of TMD, leading to improvements in pain and orofacial function. The aim of the proposed study is to analyze the effects of low-level laser therapy and light-emitting diode (LED) therapy on pain and function in patients with TMD. Methods: A randomized, controlled, double-blind, clinical trial is proposed, which will involve 80 individuals between 40 and 70 years of age allocated to either a laser group or LED group submitted to twelve sessions of phototherapy. The Research Diagnostic Criteria for TMDs will be used to evaluate all participants. Pain will be measured using the visual analog scale. Orofacial function will be measured based on maximum vertical mandibular movement and muscle tension (determined through palpation of the masseter, temporal, frontal, sternocleidomastoid, suboccipital and trapezius muscles). Electromyographic analysis of the masseter and anterior temporal muscles will also be performed.
- Being tested
- Laser Therapy, LED therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser TherapyRadiation
The groups will be submitted to 12 sessions of phototherapy held twice a week for six weeks, during which only the researcher in charge of programming the phototherapy device will be aware of which treatment is being employed. However, the programmer will not participate in the execution of the treatments, evaluations or data analysis.
LED therapyRadiation
The groups will be submitted to 12 sessions of phototherapy held twice a week for six weeks, during which only the researcher in charge of programming the phototherapy device will be aware of which treatment is being employed. However, the programmer will not participate in the execution of the treatments, evaluations or data analysis.
| Study group | Role | What they receive |
|---|---|---|
| LED group | Experimental | The groups will be submitted to 12 sessions of phototherapy held twice a week for six weeks, during which only the researcher in charge of programming the phototherapy device will be aware of which treatment is being employed. However, the programmer will not participate in the execution of the treatments, evaluations or data analysis. Receives: Radiation: LED therapy |
| Laser group | Experimental | The groups will be submitted to 12 sessions of phototherapy held twice a week for six weeks, during which only the researcher in charge of programming the phototherapy device will be aware of which treatment is being employed. However, the programmer will not participate in the execution of the treatments, evaluations or data analysis. Receives: Radiation: Laser Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
This scale will be used for the assessment of pain and consists of a 10-cm line with 0 (absence of pain) printed at one end and 10 (debilitating pain) printed at the other end. The participants will be asked to mark a place on the line that represents their current pain intensity. The researcher will subsequently use a ruler to register the distance from zero to obtain a numeric representation of the pain level. These procedures will be performed before and immediately after treatment.
Measured: Through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2017
- Study start1 May 2017
- Primary completion20 Nov 2018 (estimated)
- Study completion20 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Laser and LED Therapy on Elderly Individuals With Temporomandibular DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandra Kalil Bussadori, University of Nove de Julho
- Investigators
- Sandra K Bussadori, PhD, Principal investigator, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03257748
- Sponsor's protocol ID
- DTMLU
- Status last verified
- Oct 2018
- First submitted
- 11 Aug 2017
- Last updated
- 11 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Langella LG, Silva PFC, Costa-Santos L, Goncalves MLL, Motta LJ, Deana AM, Fernandes KPS, Mesquita-Ferrari RA, Bussadori SK. Photobiomodulation versus light-emitting diode (LED) therapy in the treatment of temporomandibular disorder: study protocol for a randomized, controlled clinical trial. Trials. 2018 Jan 26;19(1):71. doi: 10.1186/s13063-018-2444-7.
PubMed 29373998
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Laser Therapy and LED Therapy on Elderly Individuals With Temporomandibular Disorder: a Randomized, Controlled, Double-blind, Clinical Trial
- ClinicalTrials.gov ID
- NCT03257748
- Acronym / sponsor ID
- DTMLU
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 20 Nov 2018 (estimated)
- Study completion
- 20 Dec 2018 (estimated)
- First posted
- 22 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Temporomandibular disorder (TMD) is described as a subgroup of orofacial pain with a set of signs and symptoms that involve the temporomandibular joint, masticatory muscles, ears and neck. TMD can occur unilaterally or bilaterally and approximately 70% of the population is affected with at least one sign. The disorder progresses with orofacial pain, muscle pain involving the masticatory and cervical muscles, joint noises (clicks and pops), joint block, mandibular dysfunction and headache. The etiology can be abnormal occlusion and/or posture, trauma involving local tissues, repetitive microtrauma, parafunctional habits and an increase in emotional stress. Studies have demonstrated that phototherapy is an efficient option for the treatment of TMD, leading to improvements in pain and orofacial function. The aim of the proposed study is to analyze the effects of low-level laser therapy and light-emitting diode (LED) therapy on pain and function in patients with TMD. Methods: A randomized, controlled, double-blind, clinical trial is proposed, which will involve 80 individuals between 40 and 70 years of age allocated to either a laser group or LED group submitted to twelve sessions of phototherapy. The Research Diagnostic Criteria for TMDs will be used to evaluate all participants. Pain will be measured using the visual analog scale. Orofacial function will be measured based on maximum vertical mandibular movement and muscle tension (determined through palpation of the masseter, temporal, frontal, sternocleidomastoid, suboccipital and trapezius muscles). Electromyographic analysis of the masseter and anterior temporal muscles will also be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LED group | Experimental | Radiation: LED therapyThe groups will be submitted to 12 sessions of phototherapy held twice a week for six weeks, during which only the researcher in charge of programming the phototherapy device will be aware of which treatment is being employed. However, the programmer will not participate in the execution of the treatments, evaluations or data analysis. |
| Laser group | Experimental | Radiation: Laser TherapyThe groups will be submitted to 12 sessions of phototherapy held twice a week for six weeks, during which only the researcher in charge of programming the phototherapy device will be aware of which treatment is being employed. However, the programmer will not participate in the execution of the treatments, evaluations or data analysis. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of TMD based on the RDC/TMD;
- Age between 40 and 70 years.
Key exclusion criteria (5 listed)
- Dentofacial anomalies;
- Currently in orthodontic or orthopedic treatment for the jaw;
- Currently undergoing physical therapy;
- Currently undergoing psychological treatment;
- Use of muscle relaxant or anti-inflammatory agent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laser TherapyThe groups will be submitted to 12 sessions of phototherapy held twice a week for six weeks, during which only the researcher in charge of programming the phototherapy device will be aware of which treatment is being employed. However, the programmer will not participate in the execution of the treatments, evaluations or data analysis. | Radiation | Laser group |
| LED therapyThe groups will be submitted to 12 sessions of phototherapy held twice a week for six weeks, during which only the researcher in charge of programming the phototherapy device will be aware of which treatment is being employed. However, the programmer will not participate in the execution of the treatments, evaluations or data analysis. | Radiation | LED group |
Primary outcome
Visual Analog Scale
Time frame: Through study completion, an average of 1 year.
This scale will be used for the assessment of pain and consists of a 10-cm line with 0 (absence of pain) printed at one end and 10 (debilitating pain) printed at the other end. The participants will be asked to mark a place on the line that represents their current pain intensity. The researcher will subsequently use a ruler to register the distance from zero to obtain a numeric representation of the pain level. These procedures will be performed before and immediately after treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2018.
- Derived from this study: PubMed 29373998Langella LG, Silva PFC, Costa-Santos L, Goncalves MLL, Motta LJ, Deana AM, Fernandes KPS, Mesquita-Ferrari RA, Bussadori SK. Photobiomodulation versus light-emitting diode (LED) therapy in the treatment of temporomandibular disorder: study protocol for a randomized, controlled clinical trial. Trials. 2018 Jan 26;19(1):71. doi: 10.1186/s13063-018-2444-7.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandra K Bussadori, PhD principal investigator
University of Nove de Julho
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Laser Therapy and LED therapy in people with Laser and LED Therapy on Elderly Individuals With Temporomandibular Disorder, run by University of Nove de Julho at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sandra K Bussadori, PhD (+55 11 26339000, sandra.skb@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (time frame: Through study completion, an average of 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03257748, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2018.